Advice from CMDh

Information on nitrosamines for marketing authorisation holders

• CMDh letter to MAHs of tenofovir disoproxil-containing medicinal products (February 2023)

• CMDh Letter to MAHs - Impurity G in alprazolam-containing medicinal products (February 2022)

• CMDh Letter to MAHs - Risk of azido impurity in sartan-containing medicinal products (April 2021)

• Q&As on the implementation of the outcome of the Art. 31 referral on angiotensin-II-receptor antagonists (sartans) containing a tetrazole group (December 2021) [Tracked]

• Harmonised warning for ferrous sulfate-containing medicinal products on dysphagia and related bronchostenosis due to risk of aspiration (May 2018) [Tracked]

• Concomitant use of benzodiazepines/benzodiazepine like products and opioids (February 2018)

• End of pilot for splitting of MRP/DCPs (May 2020) [Tracked]

• Decisions on additional year of market protection/data exclusivity for new therapeutic indication agreed by the CMDh (December 2022)

Deletion of interaction between broad spectrum antibiotics and combined oral contraceptives (COC)

• Cover note to Public Assessment Report (March 2015)
• Public Assessment Report (March 2015) corrected in March 2016 [Tracked]
• List of ATC codes for which the change applies (January 2016)

• Harmonised traceability of gadolinium-containing contrast agents - update of Product Information wording regarding electronic patient records (February 2014)

• Monitoring of medicines originating from Japan (September 2019) [Tracked]

Bioequivalence studies conducted at GVK Biosciences Private Limited (GVK Bio), Swarna Jayanthi commercial complex, Ameerpet, Hyderabad 500 038, India (new name since 15 July 2014: Clinogent)

• Letter to Marketing Authorisation Holders (MAHs) / Applicants 
• Template for information to be submitted

Abbreviated core Risk Management Plan for bisphosphonates

• Guidance on the submission/updating of Risk Management Plans to reflect ‘atypical femoral fractures’
• Abbreviated core bisphosphonate RMP for atypical femoral fracture

EU Worksharing Procedure

• Public Assessment Report - Change in qualitative and quantitative composition of rubber stoppers of West Pharmaceutical Services (July 2008)

Questions and Answers

• Q & A on Requests for Advice from CMDh